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Completed Phase 2 Interventional Results available

Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2

ClinicalTrials.gov ID: NCT01976936

Public ClinicalTrials.gov record NCT01976936. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 8:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Safety Study in Which Ischemic Stroke Patients Will be Randomized Within 24 Hours of Symptom Onset to Placebo or Oral Lovastatin 640 mg Per Day for 3 Days.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This trial will be a phase 2 randomized safety study in which ischemic stroke patients will be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory markers and lipid levels will also be assessed.

Study identification

NCT ID
NCT01976936
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Columbia University
Other
Enrollment
162 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2009 (Actual)
Primary completion
Nov 30, 2015 (Actual)
Completion
Nov 30, 2015 (Actual)
Last update posted
Dec 1, 2025

2009 – 2015

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
University of California, Los Angeles Stroke Network Los Angeles California 90024 —
Jackson Memorial Hospital Miami Florida 33136 —
University of Miami Miller School of Medicine Miami Florida 33136 —
Emory University Atlanta Georgia 30322 —
Brigham & Women's Hospital Boston Massachusetts 02115 —
Mount Sinai School of Medicine New York New York 10029 —
The Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01976936, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 1, 2025 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01976936 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →